EU REACH

On 12 February 2019, the Commission joint Committee established under the REACH regulation, opened discussion on a proposal to amend Annex XIV of the regulation in order to list 12 additional new SVHC.

The proposal, which is based on ECHA 5th, 7th and 8th recommendations, will expand the REACH authorization list to 55 substances with sunset date up to 54 months after date of entry into force of the amended regulation.

Brexit

All companies placing chemical substances onto the markets of the European Union and European Economic Area need to prepare for the United Kingdom’s withdrawal from the EU. New instructions are now available on ECHA’s website.

ECHA recommends companies to prepare for a ‘no deal’ scenario ahead of the UK’s withdrawal on 30 March 2019.

On 17 December 2018, the UK Government published a draft statutory instrument proposing to amend UK domestic waste regulations that implement certain European Directives related to waste management to ensure the continued operation of the UK waste regime post Brexit.

The draft focuses on ensuring that regulatory alignment with the EU continues with focus on waste batteries and accumulators, end of waste criteria, packaging waste, end-of-life vehicle destruction certification, landfill acceptance criteria, the management of waste from extractive industries, and calculation methods for verifying recycling target compliance.

The draft also aims to ensure that the rules set out under the following Directives continue to apply:

  1.  Directive 91/689/EEC on hazardous waste;
  2.  Directive 94/62/EC on packaging and packaging waste as amended by Council Regulation (EC) No 1882/2003;
  3.  Directive 2004/12/EC and Directive 2005/20/EC;
  4.  Directive 2008/98/EC on waste.

The draft, once enacted, will enter into force on 29 March with the exception of Part 1 and 2 which will enter into force 21 days after the text is finalized.

USA: Significant New Use of Certain Chemical Substances

EPA reopens the comment period for the proposed rule until October 30, 2018. Comments, docket EPA-HQ-OPPT-2017-0414  – must be received on or before October 30, 2018.

On August 17, 2018 EPA proposed significant new use rules (SNURs) under the Toxic Substances Control Act (TSCA) for 27 chemical substances which were the subject of premanufacture notices (PMNs). The chemical substances are subject to Orders issued by EPA pursuant to section 5(e) of TSCA. This action would require persons who intend to manufacture (defined by statute to include import) or process any of these 27 chemical substances for an activity that is designated as a significant new use by these rules to notify EPA at least 90 days before commencing that activity.

The SNUR primarily affects Alkanes, and declares as a “significant new use” of the designated chemical substances as Flame retardants and plasticizers in PVC, polymers, and rubber; flame retardants, plasticizers, and lubricants in adhesives, caulk, sealants, and coatings; additives in lubricants including metalworking fluids; and flame retardants and waterproofers in textiles.”

California (USA): Proposition 65 Implementing Regulations, 27 Cal.Code Regulations 25102 – 27000 – Amendment (on Article 6 Clear and Reasonable Warnings), Regulation, Article 6, 2017

Excerpt:

The California Safe Drinking Water and Toxic Enforcement Act has been around since 1986; but the labeling requirements for manufacturers, retailers, and importers updated on Aug 31, 2018.  Proposition 65 requires businesses to provide warnings to Californians about significant exposures to chemicals that cause cancer, birth defects or other reproductive harm.  These chemical can be in the products that are purchased, in homes or workplaces, or released into the environment.

Content:

25600.2. Responsibility to Provide Consumer Product Exposure Warnings
The manufacturer, producer, packager, importer, supplier, or distributor of a product may comply with this article either by providing a warning on the product label or labeling affixing a label to the product bearing a warning that satisfies Section 25249.6 of the Act, or by providing a written notice directly to the authorized agent for a retail seller who is subject to Section 25249.6 of the Act…

25603 Consumer Product Exposure Warnings

(a) Unless otherwise specified in Section 25607.1 et seq., a warning meets the requirements of this subarticle if it is provided using one or more of the methods required in Section 25602 and includes all the following elements:

(1) A symbol consisting of a black exclamation point in a yellow equilateral triangle with a bold black outline. Where the sign, label or shelf tag for the product is not printed using the color yellow, the symbol may be printed in black and white. The symbol shall be placed to the left of the text of the warning, in a size no smaller than the height of the word “WARNING”.
(2) The word “WARNING:” in all capital letters and bold print, and:

(A) For exposures to listed carcinogens, the words, “This product can expose you to chemicals including [name of one or more chemicals], which is [are] known to the State of California to cause cancer. For more information go to www.P65Warnings.ca.gov.”
(B) For exposures to listed reproductive toxicants, the words, “This product can expose you to chemicals including [name of one or more chemicals], which is [are] known to the State of California to cause birth defects or other reproductive harm. For more information go to www.P65Warnings.ca.gov.”
(C) For exposures to both listed carcinogens and reproductive toxicants, the words, “This product can expose you to chemicals including [name of one or more chemicals], which is [are] known to the State of California to cause cancer, and [name of one or more chemicals], which is [are] known to the State of California to cause birth defects or other reproductive harm. For more information go to www.P65Warnings.ca.gov.”
(D) For exposures to a chemical that is listed as both a carcinogen and a reproductive toxicant, the words, “This product can expose you to chemicals including [name of one or more chemicals], which is [are] known to the State of California to cause cancer and birth defects or other reproductive harm. For more information go to www.P65Warnings.ca.gov.”
(E) Where a warning is being provided for an exposure to a single chemical the words “chemicals including” may be deleted from the warning content set out in subsections (A), (B) and (D).

(b) A short-form warning may be provided on the product label using all the following elements:
(1) The symbol required in subsection (a)(1).
(2) The word “WARNING:” in all capital letters, in bold print.
(A) For exposures to listed carcinogens, the words, “Cancer – www.P65Warnings.ca.gov.”
(B) For exposures to listed reproductive toxicants, the words, “Reproductive Harm – www.P65Warnings.ca.gov.”

Proposed Prevention and Control of Environmental Pollution by Solid Waste Draft Law

On 11 July 2018, the Chinese Ministry of Ecology and Environment published a draft revision of the Law on Prevention and Control of Environmental Pollution by Solid Waste.

The draft consists of 102 articles in 6 chapters. Compared to the current law, the draft proposes amendments on 50 articles, adding 14 new ones and deleting 4. The main amendments focus on the following:

  • Prevention of second pollution during solid waste recycling and reuse in products
  • Reduction of the volume of waste landfill by reducing solid waste and increasing recycling
  • Strengthening the responsibility of the waste producer; establishing a solid waste discharge license system
  • Extension of manufacturer’s responsibility, encouraging manufacture to improve ecodesign, establish a recycle system and promote reutilization
  • Reform on solid waste import, in particular foreign waste import
  • Establishing domestic waste sorting systems
  • Improving hazardous waste management systems
  • Stricter penalties

Public comments may be submitted online before 18 August 2018

Endocrine Disruptors are Back in the Spotlight in the EU

On June 21 2018, the EU Commission published a Roadmap informing stakeholders and citizens that it would be fulfilling its earlier commitment to establish a comprehensive framework concerning endocrine-disrupting chemicals (“endocrine disruptors”).

Scientific research has provided evidence and demonstrated that endocrine disruptors can have a significant impact on human diseases and negative impacts on wildlife.  This has created widespread political and public concern.

While they are already regulated to some extent elsewhere in various pieces of EU legislation on pesticides and biocides, chemicals in general (“REACH Regulation”), medical devices and water, this has been deemed insufficient.

The research has shown that there is particular sensitivity to endocrine disruptors of organisms in their developmental stages in many different ways.  There is increasing evidence that exposure to a combination of endocrine disruptors can produce adverse impacts at levels lower than an individual one.

Due to the complexity of the issue, the legislative changes to control usage will not happen immediately.  Questions to determine if there is a safe threshold and what the cocktail effect of exposure to multiple chemicals is, will impact the development of better legislation to deal with endocrine disruptors.  While pesticides and biocides are the primary focus, we can expect this to impact their use in all products and manufacturing processes where there can be exposures.

Our industry needs to be involved proactively to understand potential impacts to the materials we use.  By providing input into the development of a more comprehensive framework for dealing with endocrine disruptors in the EU, we can help minimize potential negative impacts to our products.

Disclosure of Hazardous Substance Information Found in Products with Vehicles in Scope

Author: California Legislative Counsel, Oct 15, 2017

Existing law regulates the existence of, and disclosure of, specified chemicals and components in consumer products, including phthalates and bisphenol A.

This bill would require a manufacturer of a designated product, as defined, that is sold in the state to disclose on the product label and on the product’s Internet Web site information related to chemicals contained in the designated product, as specified. The bill would authorize a manufacturer to protect certain chemicals from disclosure by use of a generic name, as specified. The bill would prohibit the sale in the state of a designated product that does not satisfy these requirements.

Existing law, the Hazardous Substances Information and Training Act, ensures the transmission of necessary information to employees regarding the properties and potential hazards of hazardous substances in the workplace. A serious and knowing or negligent violation of the act by an employer and every officer, management official, or supervisor having direction, management, control, or custody of any employment, place of employment, or of any other employee is a crime. Existing law requires the Occupational Safety and Health Standards Board to adopt a standard setting forth an employer’s duties toward its employees consistent with specified guidelines, including, among other things, that the employer shall make safety data sheets on substances in the workplace available to employees, collective bargaining representatives, or employee physicians.

This bill would require an employer that is required to make a safety data sheet readily accessible to an employee pursuant to that standard to make readily accessible in the same manner, for designated products in the workplace, certain information included in the online disclosures described above relating to chemicals contained in those products.

New RoHS exemption for Lead in Bearings for RoHS Cat 11

In Annex III, entry 42 is added: 42 Lead in bearings and bushes of diesel or gaseous fuel powered internal combustion engines applied in non-road professional use equipment:

– with engine total displacement ≥ 15 litres;or

– with engine total displacement < 15 litres and the engine is designed to operate in applications where the time between signal to start and full load is required to be less than 10 seconds; or regular maintenance is typically performed in a harsh and dirty outdoor environment, such as mining, construction, and agriculture applications.

Applies to category 11, excluding applications covered by entry 6(c) of this Annex.

Expires on 21 July 2024.

California Safer Consumer Products Priority Product Work Plan for 2018-2020

The California Department of Toxic Substances Control (DTSC) has published their three-year Priority Product Work Plan. Two of the categories that impact the automotive industry are Cleaning Products (carried over from the last three-year plan) and Lead-Acid Batteries.

Cleaning Products

“Automotive Product” means a chemically  formulated consumer product labeled to indicate that the purpose of the product is to maintain the appearance of a motor vehicle, as defined in Section 670 of the Vehicle Code, including products for washing, waxing, polishing, cleaning, or treating the exterior or interior surfaces of motor vehicles.  “Automotive Product” does not include automotive paint or paint repair products.

Lead Acid Batteries

Lead-acid batteries are found in a wide variety of forms and functions, the most common being 12-volt car batteries. Lead-acid batteries contain three Candidate Chemicals: lead, arsenic, and sulfuric acid.  Inclusion of this category in the Work Plan allows DTSC to finalize evaluation of lead-acid batteries as a potential Priority Product.

DTSC established goals for the 2018-2020 Work Plan include:

  • To protect children from exposures to harmful chemicals from consumer products, especially carcinogens, mutagens, reproductive toxicants, neurotoxicants, developmental toxicants, and endocrine disruptors.
  • To protect workers from exposures to harmful chemicals from consumer products.
  • To protect California’s valuable and limited water resources and aquatic ecosystems from consumer product-derived chemical contamination.

DTSC stakeholder participation is needed as these actions are reviewed for these priority products.

ECHA asks for input about their proposal for Downstream User communication requirements

ECHA is seeking industry input, especially from downstream global users about the proposed process they plan to inform the public about uses of Substances of Very High Concern.

ECHA’s intended approach is to share non-confidential information from the notifications with the public and specific anonymized information with companies that applied for and received Authorization. This transparent approach aims to maximize the usefulness of notifications while respecting confidentiality concerns (for example, as regards confidential business information, information that would raise competition law issues, personal information).  The REACH-IT tool has been modified to allow for company import of data on SVHC uses, include where, what, why and how.  The expectation that alternatives will drive notification from companies that they no longer use an SVHC is a key feature.  However, many areas of the world have restrictions about what business information (ex. Contact names) is allowed to be a required disclosure.

Information that will always be made public (green):

  • Substance
  • Member State where the use takes place
  • Whether the notification’s status is active or inactive (substituted/ceased use)[1].

Information that will be made public unless the Downstream User has claimed this information confidential and has provided a valid justification (grey). ECHA will also consult with the Authorisation Holder about the confidentiality of such information about their Downstream Users:

  • Name of the company which notified the use
  • Location of the site
  • Name of the authorised use concerned by the notification
  • Any quantity information provided.

Information that will not be made public (red):

  • Name of the upstream supplier which holds the authorisation for the notified use
  • Information that can be personal such as the email address and the telephone number provided in the notification
  • Any voluntary information provided about the authorised use, except from the quantity (number of staff involved in the use, brief additional description of the specific use, involvement in substitution activities)
  • Any file attachments uploaded by the Downstream User.

Important Points:

  • Companies can mark their notification as inactive in REACH-IT. This is relevant in case they have stopped use of the SVHC, e.g. because they have now implemented an alternative substance or technology.
  • It should also be noted that Article 118(2) of REACH provides – inter alia – that the disclosure of the precise tonnage of the substance or mixture and disclosure of links between a manufacturer or importer and his distributors or downstream users shall normally be deemed to undermine the protection of commercial interests.

[1] Companies can mark their notification as inactive in REACH-IT. This is relevant in case they have stopped use of the SVHC, e.g. because they have now implemented an alternative substance or technology.